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临床试验/NCT04093674
NCT04093674已完成不适用

Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Double Blade Scalpel (DBS) and De-epithelized (DE) SCTG Associated With Coronally Advanced Flap (CAF): a Split-mouth Randomized Clinical Trial

University of Sao Paulo0 个研究点目标入组 21 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
主要终点
Percentage of root coverage based on Recession depth at baseline and after 6 months

研究概览

简要总结

This split-mouth randomized clinical trial compared two different types of subepithelial connective tissue grafts (SCTG) considering clinical parameters and patient-centered outcomes in patients with bilateral RT 1 multiple gingival recessions after 6 months postoperatively. 21 patients with 84 sites were surgically treated with coronally advanced flap (CAF) associated with SCTG harvested by: double blade scalpel (DBS) and de-epithelized (DE) SCTG. Periodontal clinical parameters and aesthetics were evaluated by a calibrated periodontist at baseline and after 6 months. Patient-centered outcomes related to pain/discomfort and aesthetics were assessed with Visual Analogue Scale (VAS) after 7 days and 6 months, respectively. Gingival blood flows were analyzed by Laser Doppler flowmetry (FLD) at baseline and 2, 7 and 14 days postoperatively.

详细描述

Clinical parameters and patient-centered outcomes

Periodontal clinical examination was performed by a blind and calibrated examiner (intra-class correlation coefficient = 0.72) using a North Carolina periodontal probe (PCPUNC-Hu-Friedy®). Periodontal parameters were evaluated at baseline and after 6 months postoperatively and included:

  1. Recession depth (RD) - Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth;
  2. Recession width (RW) - Distance between interproximal gingival margins of GR with periodontal probe positioned at CEJ;
  3. Probing depth (PD) - Distance in millimeters from the gingival margin to the bottom of the gingival sulcus;
  4. Clinical attachment level (CAL) - Distance in millimeters from the CEJ to the bottom of the gingival sulcus;
  5. Keratinized tissue width (KTW) - Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth;
  6. Keratinized tissue thickness (KTT): determined 1.5 mm apically to gingival margin with an anesthesia needle and a rubber endodontic stop inserted perpendicularly into the soft tissue and measured with a digital caliper.

The index proposed by Zucchelli & DeSanctis (2000) was used to calculate percentage of root coverage (%RC), as follows:

RRC=(100.(RD baseline-RD 6 months))/(RD baseline) Patient centered outcomes and professional assessment were evaluated with visual analog scales (VAS). VAS was administered verbally to the patients to assess aesthetics and postoperative pain/discomfort. Patients were asked to make a mark in a scale between 0 (not satisfied or extreme pain) and 10 (very satisfied or no pain). Pain and discomfort were recorded after 7 days and patient´s aesthetic evaluation after 6 months. An experienced periodontist (intra-class correlation coefficient = 0.95) evaluated aesthetic outcome after 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy patients between 18 and 70 years
  • clinical diagnosis of bilateral multiple gingival recessions, recession type (RT) 1 (Cairo et al. 2011) with at least one gingival recession ≥ 2 mm on each side, including canines and premolars.

排除标准

  • abnormal teeth position
  • smokers, pregnant or nursing women
  • parafunctional habits
  • plaque and bleeding indexes (Ainamo & Bay, 1975) above 20%
  • previous periodontal surgeries on selected sites.

结局指标

主要结局

Percentage of root coverage based on Recession depth at baseline and after 6 months

时间窗: 6 months

Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth

次要结局

  • Variation on: Recession width (RW) comparing baseline measurements to 6 months.(6 months)
  • Pain and discomfort- Patient centered outcomes(7 days)
  • Esthetics-Periodontist evaluation(6 months)
  • Variation on: Keratinized tissue thickness (KTT) comparing baseline measurements to 6 months.(6 months)
  • Variation on: Keratinized tissue width (KTW) comparing baseline measurements to 6 months.(6 months)
  • Esthetics-Patient centered outcomes(6 months)
  • Variation on: Probing depth (PD) comparing baseline measurements to 6 months.(6 months)
  • Variation on: Clinical attachment level (CAL) comparing baseline measurements to 6 months.(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariana Ragghianti Zangrando

Assistent Professor

University of Sao Paulo

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